Protecting Product Integrity - Sentry BioPharma · BioPharma Services, Inc. Validation complete and...

TEMPERATURE • PACKAGING • DISTRIBUTION • CLINICAL TRIALS • CUSTOM SOLUTIONS

Protecting Product Integrity


www.sentrybps.com | 1-866-757-7400

Sentry BioPharma Services, Inc.

• Celebrating 10 Years of

Service

• Contract Service Provider

• Privately held company

• Extensive Industry Experience

• Exclusively serves life science

industry

• Commitment to grow with the

needs of our clients

http://www.sentrybps.com/

• History

• Location and Facility

• Security

• Quality and Regulatory

• Capabilities

• Storage Solutions

• Vaccine Management

• Controlled Substances

• Foreign Trade Zone

• Secondary Labeling, Kitting &

Packaging




2005

Pharmaceutical, cold

chain management and

quality assurance

experts create Sentry

BioPharma Services,

Inc.

Validation complete

and first product

arrives at facility

2006 Approved by the

NABP and awarded

VAWD accreditation

2007

History



DEA import

license

approved

2008

Sentry’s CSIII-V

cages inspected

and approved

by the DEA2010

100th Client

2016


Location

• Central Location with Global Reach

• Close proximity to Indianapolis

International Airport (IND)

• Adjacent to FedEx ground and air

hubs (2nd Largest Worldwide)

• Extensive Interstate Access

• I-65, I-69, I-70 and I-74

• 75% U.S. within 1 day truck drive



http://indy.cciconstellation.net/Prospect-Portal.aspx


2nd Largest FedEx Air Hub“IND”

International AirportFedEx Freight

Sentry BPS




Facility



• State-of-the-art Facility

• Built to Factory Mutual

(FM) Specifications

• Validated Systems &

Environments

• Rapid Expansion

Capabilities

• Redundant Systems


Security and Transparency

• 24/7 Sonitrol/Stanley monitoring system

• Access Restriction

• Closed Circuit TV system

• Building Management System

• Local and remote building alerts

• Perimeter fence and gate

• Encrypted Client Inventory Access

• Automated Activity Notifications




Quality and Regulatory

• 21 CFR, Part 210 & 211 Compliant

• FDA Labeler Code - 32405

• Robust Regulatory History

• Destruction Management Program

• Returns Management Program

• VAWD® Accredited

• Licensed in all 50 states and U.S.

Territories




Regulatory Snapshot

Inspected regularly by:

• FDA – Food and Drug Administration

• USDA – United States Department of Agriculture

• PMDA – Pharmaceuticals and Medical Devices Agency (Japan)

• MHRA – Medicines and Healthcare products Regulatory Agency

(U.K.) on behalf of the EMA

• DEA – Drug Enforcement Administration

• FAA – Federal Aviation Administration

• NABP – National Association of Boards of Pharmacy

• CBP – U.S. Customs and Border Protection




Agency Scope Date

Drug Enforcement Administration (DEA)Routine Compliance

Inspection12/12/2016

National Association of Boards of Pharmacy® (NABP®)Triennial Reaccreditation

Site Survey10/06/2016



US Customs and Border Protection (CBP) General 07/07/2016

Food and Drug Administration (FDA)Routine Surveillance


Federal Aviation Administration (FAA), Security and Hazardous MaterialsRoutine Compliance


United States Department of Agriculture (USDA) Client-specific 10/28/2014

Pharmaceuticals and Medical Devices Agency, (PMDA), Japan Registration Renewal 07/28/2014

US Customs and Border Protection (CBP) General 06/20/2014

National Association of Boards of Pharmacy® (NABP®)Triennial Reaccreditation

Site Survey06/11/2014





Food and Drug Administration (FDA) Client-specific 03/19/2013

United States Department of Agriculture (USDA) Client-specific 08/14/2012

Medicines and Healthcare products Regulatory Agency (MHRA) Client-specific 03/13/2012






Storage Solutions• 53,000 square feet

• GMP Storage

• Ambient +15°C to +30°C

• Refrigerated +2°C to +8°C

• Frozen -15°C to -25°C

• Low Temp. Frozen -33°C to -43°C

• Custom Frozen -40°C to -60°C

• Ultra-low -70°C to -90°C

• Custom Temperature Solutions

0°C to -90°C

• DEA Controlled Substance (CSIII – V)

• Foreign Trade Zone (FTZ) available across all storage conditions




• Seasonal/Pandemic Solutions

• Vaccine and bio-defense

product storage and rotation

combined with executable plans

for epidemic or pandemic surge

distribution support

• Multiple U.S. Government

Awards with the CDC and HHS

Vaccine Management Solutions





Supply Chain Management

Sentry’s Global Reach

• Cold Chain Management

• Domestic and Global Distribution

• Cross-docking

• Channel Qualification

• Import Optimization

• Foreign Trade Zone (FTZ)




Sentry’s Global Footprint


Current Stats:

• >21,400 Shipments

and Receipts

• >32 Countries Served

• Clients across 10 time

zones

• <1/10 of 1% Error Rate


Manufacturing Support

• Labeling

• Clinical and Small-Scale

Commercial

• Temperature-Sensitive

Products

• Open and Blinded

• Serialized

• Randomization

• Multilingual

• Peel-off / Perforated




Manufacturing Support

• Secondary Packaging

• Bulk packaging

• Single- / Multi-dose cartons

• Package Inserts

• Kits

• Double-blind Packaging

• Tamper-evident





If you have questions:

email [email protected] or call 1-866-757-7400



mailto:[email protected]

Protecting Product Integrity - Sentry BioPharma · BioPharma Services, Inc. Validation complete and...

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